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Sponsor Change for 54 NADAs, 1 ANADA to Zoetis

02/27/2014

FDA Amends Animal Drug Regs to Reflect Withdrawals

02/27/2014

Comments Sought on Rx Drug Ad Info

02/27/2014

OMB OKs Info on Tobacco Prevention Campaign

02/27/2014

Federal Register Notice: FDA’s collection of information entitled “Evaluation of the Food and Drug Administration&rsqu...

Guidance on Fixed-Combination Drug Products

02/24/2014

Comments Sought on Drug Supply Chain Requirements

02/24/2014

Federal Register Notice: FDA is establishing a public docket to receive information and comments on standards for the interoperabl...

Hearing On OTC Drug Review

02/24/2014

Federal Register Notice: FDA will hold a public hearing 3/25-26 to obtain input on the Over-the-Counter (OTC) Drug Review (sometim...

CDER Seeks Firms for Site Tours Program

02/21/2014

Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Intera...

OMB OKs Info on CGMPS, QSRs

02/21/2014

Federal Register Notice: FDA’s collection of information entitled “Current Good Manufacturing Practice (CGMP); Quality...

FDA Withdraws Phenylproponolamine Products

02/20/2014

Federal Register Notice: FDA is withdrawing approval of 13 NDAs and 7 ANDAs for products containing phenylpropanolamine. The produ...